Products and Services

At the heart of everything we do – we put patients first.

We aim to make a difference for patients when they are most vulnerable: in emergency medicine, in intensive care, in specialty care, and when requiring long-term care in hospital and ambulatory settings.

Chronic diseases are on the rise worldwide. A growing number of people need access to high-quality therapies. In the care of critically and chronically ill patients, the requirements for improved clinical outcomes are increasing. Consequently, the demand for effective therapies together with intelligent medical applications and devices will also steadily rise.

Patient and Product Safety

Fresenius Kabi’s corporate mission “caring for life” describes our commitment to improving the quality of life of our patients. The quality and safety of our products and services is therefore of paramount importance. A goal of the quality management at Fresenius Kabi is to monitor the applicability, efficacy, and safety of products and services, the success of therapies, and the continuous improvement of both. To ensure this, we have established an integrated quality management system, a monitoring and reporting system, and product risk management.

Ensuring Highest Product Quality

To provide patients with the best possible care, we offer them products that meet strict requirements for quality and safety. Fresenius Kabi’s quality management system is organized in accordance with the ISO 9001 standard and is binding for all organizations.

Compliance with the standard is reviewed by TÜV Süd in annual audits at a global level and covers 102 organizations through a matrix certification; further organizations hold local ISO 9001 certificates. In addition, numerous manufacturing plants are also certified according to ISO 13485 for medical devices as well as good manufacturing practice (GMP).

Audit and Inspection Score

Fresenius Kabi regularly conducts internal quality audits to ensure the effectiveness of the qualtiy management system and compliance with internal and external standards and requirements. Inspections by regulatory authorities and audits by independent organizations and customers are performed along the entire value chain at Fresenius Kabi.

The external audits and inspections in 2021 comprised a total of 30 inspections (2020: 21) regarding Good Manufacturing Practices (GMP) by the U.S. Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), Canada Health, European regulatory authorities, and Quality System audits from TÜV Süd (notifying body for ISO 9001).

Based on the respective observations, an audit and inspection score¹ is calculated. It was 1.9 in 2021 (2020: 1.3). Observations have been and will be addressed by corrective and preventive actions and effectiveness checks have been and will be defined.

¹ For the calculation of the audit and inspection score, Fresenius Kabi takes into account all information on findings from audits and inspections received by the company before December 31, 2021.

Driving Innovation and Digitalization in Healthcare Markets

For a global healthcare company that offers lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition, digitalization and innovation are of great importance. The digitization of processes is a cornerstone in the development of innovations and an important aspect in effective care for critically and chronically ill patients, as well as compliance with regulatory requirements.

Fresenius Kabi develops digital applications for healthcare professionals and patients to support the quality of treatment and to improve patient care and quality of life, as well as to open up new business areas. In addition, we use digital solutions such as track-and-trace systems for the traceability of products. These applications also enable information to be shared with customers, and support, for example, the monitoring of inventories in hospitals. As part of this engagement, we introduced, for example, radio frequency identification (RFID) technology for drug labeling in the US market in 2020. The smart labels enable hospitals to automatically identify, locate, and manage their inventory.

In the area of devices, Fresenius Kabi works on solutions for interoperability between pumps, infusion-specific systems, and hospital IT. Our main goal: improving efficiency and effectiveness in the treatment of patients. Furthermore, devices are constantly improved with regard to new cybersecurity requirements.

Access to Medicine and Support of Healthcare Systems

Fresenius Kabi is committed to improving the quality of life of patients around the globe. As part of this commitment, we are dedicated to improving access to medicines for people worldwide. Fresenius Kabi continued its activities in response to the ongoing COVID-19 pandemic and adapted them to the changing environment.

Fresenius Kabi is in regular exchange with the Access to Medicine Foundation with regard to the Antimicrobial Resistance (AMR) Benchmark. In this benchmark, selected manufacturers of generic drugs are regularly evaluated in the categories of Appropriate Access, Stewardship, and Responsible Manufacturing. Fresenius Kabi is evaluated in the AMR Benchmark as an important manufacturer of generic antibiotic products. We consistently score highly and have improved our rating in the AMR Benchmark 2021 compared to the previous evaluation. In the category of generic manufacturers, Fresenius Kabi performs overall above average, thus, recognizing the company’s efforts with regards to AMR, in particular to its performance in the categories Stewardship and Responsible Manufacturing.

In addition, Fresenius Kabi has been a member of the AMR Industry Alliance since 2020 and has been actively involved in the association’s governing bodies since 2021. As a member, we strive to follow the guidelines of the Common Antibiotic Manufacturing Framework (CAMF) to further improve our environmental management in this area. For example, the CAMF includes limits on the discharge of wastewater contaminated with antibiotic residues. Fresenius Kabi has started to implement appropriate measures and controls for discharge of wastewater at its 18 antibiotic-producing or antibiotic-using sites.